Drugs

CGMP Violations at HomeoCare Laboratories

David McFarland

— 2 min read
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A 1/4-1/11 FDA inspection at HomeoCare Laboratories, Yonkers, NY, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 9/7 Warning Letter. The letter says the inspection also determined that the firm’s products HBP Relief, Cholestop, and IBS Relief are misbranded. Specific violations noted in the letter were: 

  •          failing to establish adequate written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess, and failing of the firm’s quality control unit to review and approve the procedures, including any changes;
  •          failing to establish and follow adequate written procedures designed to assure batch uniformity and integrity of drug products that describe the in-process controls, and tests, or examinations to be conducted on appropriate samples of in-process materials of each batch;
  •          failing to conduct at least one test to verify the identity of each component of a drug product and failing to establish the reliability of component supplier analyses on which the firm relies in lieu of certain tests through appropriate validation of the supplier’s test results at appropriate intervals; and
  •          failing to maintain written records so that data in them could be used for evaluating, at least annually, the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures.

The letter says that HomeoCare “does not have an adequate ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality.” It strongly recommends that considering the nature of the violations, the firm engage a qualified consultant to assist it in meeting CGMP requirements.

The letter also says that the firm’s three products cited in the Warning are considered to be drugs because they are intended to diagnose, cure, mitigate, treat, or prevent disease and/or intended to affect the structure or any function of the body. “Because of their toxicity or other potential for harmful effect, or the method of their use, or the collateral measures necessary to their use,” FDA says, “HBP Relief, Cholestop, and IBS Relief are not safe for use except under the supervision of a practitioner licensed by law to administer such drugs.” FDA continues that the three drugs are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. And it says that adequate directions cannot be written so that a layperson could use the product safely for those indications.

The letter acknowledges that the drugs are labeled as homeopathic drugs with active ingredients measured in homeopathic strengths. It notes that homeopathic drugs are subject to the same regulatory requirements as other drugs, and says that the Compliance Policy Guide for homeopathic drugs states that homeopathic products offered for conditions not amenable to over-the-counter use must be marketed as prescription products.

The company was told to correct the violations promptly and to respond with a list of steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.

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